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The Risk Surveillance Lead drives the adoption and implementation of Risk-Based Quality Management (RBQM) practices across clinical trials. They facilitate protocol risk assessments, conduct central surveillance of aggregate data, and lead cross-functional teams to identify and mitigate quality risks.
Candidates must hold a Bachelor’s degree in a health-related or life science field and possess at least 4 years of experience in the pharmaceutical or CRO industry. A robust understanding of drug development, clinical trial execution, and regulatory standards like ICH E6 and 21 CFR Part 11 is required.
Major Accountabilities:
Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined
Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP)
Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system
Conduct of periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issues
Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies
Supports and participates in internal and external audits and inspection
Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.
Identifies and shares lessons learned, best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes
Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit
Experience:
Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience
Minimum of 4 years of experience in the pharmaceutical or CRO industry
Preferred minimum of 1 years of experience in Risk Based Quality Management
Robust understanding of the drug development process and clinical trial execution
Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
Knowledge of RBQM IT systems or other data analytic systems
Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
Demonstrated ability to effectively lead cross functional team meetings
Experience forming cross-functional collaborations; strong interpersonal skills
Supports a culture of continual improvement and innovation; promotes knowledge sharing
Ability to influence without authority
Thinks creatively; challenges the status quo
Languages:
English: fluent written and spoken
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
The expected Annual Base Salary Range for this role: 63,600.00 - 118,000.00 EUR Annual
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering:
https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Find out more at https://www.novartis.com See our community guidelines: https://go.novartis.social/3Nboxki
Offices: Novartis Campus, Basel, Baselstadt 4002, CH · One Health Plaza, East Hanover, NJ 07936, US · Calle 93B S-31, Bogota, Bogota, D.C. 110541, CO · Merrion Road, Dublin, County Dublin, IE · Na Pankraci 1724/129, Prague, Prague 140 00, CZ
